I. Peer-Review Process

How long does the peer-review process take?

Once the Draft Final Research Report (DFRR) enters external peer review, the process will take about six months. This includes review by external reviewers and associate editor; two months for the author’s response; final associate editor comments; and final review by PCORI’s Program Director for Peer Review.

Peer review may take more than six months if the associate editor or PCORI’s program director find that more than one revision is necessary, or if there are delays in submitting the revisions.

How much time and resources should I set aside to write and revise the DFRR?

PCORI recommends that you start preparing the DFRR at least one year before the due date by writing the Background, Patient and Stakeholder Engagement, and Methods sections before you have your results. Preparing the report and responding to reviewer comments can take around 100 hours over the seven to eight months estimated in the timeline. Be sure that you have set aside time to complete this work as well as ensure access to an assistant to compile materials and a statistician to help write the Methods section on statistical analysis and address reviewer comments. You will not be asked to do new statistical analyses, but you may be asked to provide more information about the analyses presented in your report.

How will authors get the results of the peer review?

The corresponding author will receive decision letters through email but will only access specific comments from reviewers and editors in the ReView system. The first decision letter will be a synthesis letter, sent after external peer review, which will include: the associate editor’s summary of the strengths of your report; any important problems that the reviewers identified; and instructions for accessing the individual peer-reviewer comments, the associate editor’s comments, and the marked-up versions of the DFRR in ReView. Authors will receive all communications from the same mailbox.  If the authors have questions, they should contact [email protected].

How long do awardees have to respond to reviewers’ comments?

As noted in PCORI’s Process for Peer Review of Primary Research and Public Release of Research Findings, awardees have 45 business days (about two months) to respond to external reviewers’ comments. However, we are willing to work with awardees to adjust these deadlines as circumstances arise. If editors request additional revisions, awardees will have two to four weeks to respond, depending on the extent of the revisions.

I can’t complete my responses to peer review before the revisions are due. What should I do?

We understand that research, clinical, administrative, and personal responsibilities can interfere with your ability to complete your revisions on time. If you feel that you need more time for revision, please contact [email protected] to request an extension. Ask for a realistic extension but also consider that you have to complete peer review before your PCORI contract ends. If there are specific comments from reviewers that are causing delays in revisions, PCORI program staff and the associate editor assigned to your report will be happy to discuss how to address the reviews.

Who do I contact for questions?

The PCORI peer-review office and peer-review contractor are available to answer your questions and help improve your peer-review experience.  In general, the PCORI peer-review office ([email protected]) handles requests for extensions on your report revision deadline and all communications related to the formatting, copyediting, and posting of your Final Research Report (FRR) once it is accepted. However, requests for changes of original submission date or requests for additional funding should go directly to your Science Program Officer and Associate.  The peer review contractor office ([email protected]) responds to any technical questions such as using the ReView peer review system and alerts your associate editor regarding all of your scientific questions. If you would like to speak directly to any PCORI peer-review staff and contractor personnel, contact the Author Services team at [email protected].

II. Preparing Draft Final Research Reports

What results have to be included in the DFRR?

The DFRR must include all of the research that PCORI funded you to complete. This should include the background, methods, and results for all specific aims and any exploratory analyses that your program officer approved. If any work is missing from the DFRR, it will be considered incomplete and fail to meet your contractual requirement to submit this report.;

My DFRR is due, but I haven’t finished all of my analyses. Can I add the rest of the results during peer review?

No. The DFFR must include a complete account of all analyses and results when it is submitted. The report will be checked for completeness before entering peer review. Incomplete reports will be returned to the principal investigator.

What is the difference between the final progress report and the DFRR? Both are due at the end of the study.

The final progress report documents the final phase of the study. It includes how the study was completed; whether the team met the milestones set forth in the contract; any challenges encountered; remedial actions taken in mitigating and resolving concerns, including risks to study completion; and notable accomplishments. Study findings are not typically included in the final progress report. PCORI staff review the final progress report, but it is not publicly disclosed.

In contrast, the DFRR documents all of the work completed in the PCORI-funded study. This report must include a detailed description of the study’s background, methods, results, and conclusions, consistent with PCORI’s Process for Peer Review of Primary Research and Public Release of Research Findings. The DFRR goes through external peer review, and the awardee may revise it before PCORI accepts it as the FRR. This FRR will be posted on the PCORI website on the project’s web page. It will be freely accessible and available for anyone to use.

What can be included in the appendices and how many appendices can I include?

There is no limit to the number of appendices you can include with your DFRR. However, all appendices must be referenced in the report narrative and serve a purpose in explicating elements of the report. Common uses for appendices have been copies of intervention materials and manuals; additional, post hoc data analyses; and data codebooks. The appendices are separate from the required attachments to be submitted with the DFRR. The Instructions to Awardees provide more detail on how to submit appendices and these required attachments.

How polished must the DFRR be?

The FRR will be publicly accessible on the PCORI website. Therefore, the DFRR should be as polished as if it were being submitted to your preferred journal. Please follow the formatting guidelines outlined in the Instructions to Awardees. The submitted DFRR should be carefully edited to make sure that the report is clear and understandable. It should include all analyses and results planned in the study protocol and statistical analysis plan. If the report does not meet the submission requirements, it will be returned for revisions before moving forward to review. The Author Services team can help you make sure that you have prepared the report and related materials correctly. Contact the Author Services team at [email protected].

Manuscripts with our study’s main findings have been peer reviewed and published in a journal. Can I submit my published article as my report?

No, but you may incorporate parts of published manuscripts as described below. The DFRR must follow the Instructions to Awardees to be considered adequate for peer review. Peer-reviewed journal articles also tend to focus on only part of the research conducted in a funded study, whereas the DFRR should include a full accounting of the methods and analyses planned in the study protocol. The word count of the DFRR is similar to the combined word count of three to five regular journal articles (maximum length of 15,000 words).

Can I use parts of the published manuscript in the DFRR, such as previously published tables and figures?

Yes. The DFRR can include information such as tables, figures, and sections of text from previously published journal articles (see the Instructions to Awardees for detailed instructions for including these materials). You should cite the source of material taken directly from such publications (i.e., figures, tables, and text). Awardees are responsible for checking with the journal publisher and, if necessary, getting permission for reprinting or using any part of the published article in the DFRR, which will be made publicly available on PCORI’s website following peer review. Authors should comply with all of the stipulations set by the journal publisher. Please note that the permissible use of previously published content may depend on the length of text and whether the authors transferred copyright to the journal. Please include a copy of any relevant copyright permissions or licenses for PCORI’s records as a separate file with your submission of the DFRR. Remember that the author, not PCORI, is liable for any unauthorized duplication of material from previously published articles.

Who counts as an author for the DFRR?

You can make the decision about who to include as an author on the report, however, you should follow standard guidelines about who should be considered an author. Each author should meet all of the International Committee of Medical and Journal Editors (ICME) authorship requirements below:

1. Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work
2. Drafting the work or revising it critically for important intellectual content
3. Final approval of the version to be published
4. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved

Source: International Committee of Medical and Journal Editors (May, 2022), “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.” https://www.icmje.org/icmje-recommendations.pdf

Remember that the principal investigator and their institution are responsible for collecting and attesting to the conflict-of-interest information from all listed authors, including authors at different institutions.

III. Completing the Ancillary Information Conflict of Interest (COI) Disclosure Form

Who needs to complete and sign the Ancillary COI Disclosure Form?

The Ancillary Information COI Disclosure Form captures COI information related to the study and FRR as listed in our authorizing law:

The institution that received the study funding (i.e., awardee institution) is responsible for completing the COI form and verifying whether any key personnel on the project have a conflict of interest related to the research project. The principal investigator and an administrative official from the awardee institution must sign the COI form for it to be considered complete.

What does PCORI consider to be a conflict of interest?

PCORI has modeled aspects of the COI form based on the National Institutes of Health Grants & Funding policy. For more information on this policy, please visit https://grants.nih.gov/grants/policy/coi/index.htm.

A conflict of interest is defined as any financial or business associations or personal associations related to health care (e.g., if you or someone in your immediate family has worked for or volunteered for a healthcare-related organization, holds a patent for a medical device, or owns an individual stock in a medical product manufacturing company).

Do all key personnel from the study have to be on the same COI form?

All current key personnel on the research project, even those from institutions other than the sponsoring institution, should be listed on the same COI form, even if they are not all listed as authors on the DFRR. If you have had any changes in key personnel, please inform your assigned program officer or program associate so they can make the appropriate updates in the project record. The institution completing the COI form can add extra pages if they need additional space.

Do awardees have to submit their COI form at the same time as the DFRR?

In general, awardees should submit their COI form at the same time as their DFRR. However, PCORI understands that different institutions have different processes for signing off on conflict disclosure documentation. If the COI form is not complete by the time you are due to submit your DFRR, please notify the PCORI Peer Review Office ([email protected].

IV. Posting of Peer-Reviewed Materials

What will be posted on PCORI’s website after the peer-review process is complete, and when will it be posted?

As noted in PCORI’s Process for Peer Review of Primary Research and Public Release of Research Findings document, approved by the Board of Governors, PCORI will post the following within 90 days of accepting the FRR:

• A public-facing research summary developed by the PCOR Translation Center after review by the awardee (with audio and Spanish translations available)
• A 500-word abstract for medical professionals, also developed by the Translation Center.
• A link to the study results tables on ClinicalTrials.gov (as applicable)
• The completed COI Disclosure Form

Within 12 months of accepting the FRR, PCORI will post the following:

• A summary of the major peer-review comments and author responses
• The FRR with accompanying appendices
• The final study protocol

What information is posted online about the peer review of the DFRR?

As with any peer-review process, the editors and content experts who review the DFRRs often ask the researchers to address concerns about the way they conducted the project, their results, and their conclusions. PCORI will prepare a summary of three to five points from peer review, including what reviewers commented and how the authors responded. The peer review summary will be posted on the project’s PCORI web page to help readers understand what changed in the report as a result of the peer-review process.

On rare occasions, researchers might disagree with a reviewer’s comment that is key to interpreting their study results. When that disagreement cannot be resolved, PCORI describes it in the peer-review summary and invites the report authors to submit a brief explanation of their reasoning. Such statements are limited to 200 words and subject to review by PCORI program staff. Any such awardee response will be posted online with the peer-review summary.

Awardees have an opportunity to review the peer-review summary. We do not expect awardees to ask to write a response to the peer-review summary when there are no unresolved issues. But if an awardee does so or asks for changes to the summary to make the language clearer, we will consider such requests on a case-by-case basis.

After the FRR is posted to the PCORI website, may awardees request changes to the report?

Yes, requests to correct errors or change results so that they align with findings published elsewhere are allowed. If you want to change something in your FRR, contact [email protected] to discuss the extent of the changes. If there are errors in the FRR we will remove the report from our website until you correct them. Before reposting, we will review all proposed changes to determine whether the report needs to go back to the associate editor for re-review if there is a significant change to the final report or any changes to the study conclusions.

Before posting the revised FRR, PCORI will add an erratum statement on the title page to explain and date the changes and update the recommended citation and copyright statement to note the year of reposting.

Is posting results tables to ClinicalTrials.gov considered prior publication? What about the summaries or abstracts posted on PCORI’s website?

Most journals do not consider posting of results on a registry like ClinicalTrials.gov or in summaries of 500 words or less to be prior publication. PCORI’s policy regarding the posting of these results conforms to the recommendations of the International Committee of Medical Journal Editors (ICMJE): “The ICMJE will not consider as prior publication the posting of trial results…if results are limited to a brief (500 word) structured abstract or tables (to include patients enrolled, key outcomes, and adverse events).”

Please let the PCORI peer review office know if a journal editor raises concerns so that we can contact him or her directly to discuss them.

Similarly, the ICMJE does not consider as prior publication the author’s requirements under the Food and Drug Administration Amendments Act of 2007, U.S. Public Law 110-85, Title VIII, to post results tables on ClinicalTrials.gov. For more information, see:

• ICMJE Statement: http://www.icmje.org/recommendations/browse/publishing-and-editorial-issues/clinical-trial-registration.html
• ICMJE FAQ: http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/

Are there any restrictions on where awardees can publish articles based on PCORI-funded research? For example, are awardees expected to publish only in open-access journals?

Awardees may publish articles resulting from PCORI-funded projects in any journal at any time. We expect that awardees will notify us when they submit manuscripts to journals and when journals accept those manuscripts for publication. We also ask that awardees inquire about open-access options because of our interest in linking to the published articles from our website. For more information about PCORI’s policy, please refer to Public Access to Journal Articles Presenting Findings from PCORI-Funded Research.

If the FRR posts no later than 12 months after acceptance, what will happen if a manuscript describing that work has not yet published in a peer-reviewed journal? Most journals require that the information in submitted manuscripts not be published previously.

PCORI will work closely with awardees, investigators, and journals to coordinate posting of the FRR with publication of manuscripts in press. However, we must balance journal publication with our obligation under our authorizing law, affirmed through public comments on our draft Peer-Review Process document, to make the results of PCORI-funded research widely available to the public as expeditiously as possible. The document states, “PCORI may delay posting beyond 12 months to coordinate posting with publication of a peer-reviewed journal version of study findings." We will post the FRR at 12 months unless the author has received a revise and resubmit letter from the journal.

Posted: March 27, 2017; Updated: October 19, 2022